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ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration (Rockville, MD, www.fda.gov) will hold a public meeting in the fall of this year to gather information about current developments in the uses of nanotechnology materials in FDA-regulated products.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Sandoz (Holzkirchen, Germany), the generics division of Novartis (Basel, Switzerland) received European marketing authorization for its recombinant human growth hormone, ?Omnitrope? (somatropin), making it the first biogeneric product approved under the biosimilar pathway of the European Commission.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Total employment in the biosciences in the United States reached 1.2 million in 2004, the latest year for which data are currently available, according to the study, "Growing the Nation's Bioscience Sector: State Bioscience Initiatives 2006," which was released this week at BIO 2006

The US Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) is again extending an invitation to biologics facilities for participation in its Regulatory Site Visit Training Program (RSVP). The program, initiated in 2005, aims to give CBER's regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities and allow CBER staff to directly observe routine manufacturing practices. The objective is to give its staff a better understanding of the biologics industry, including its challenges and operations, and improve communication with CBER staff and industry.

ePT--the Electronic Newsletter of Pharmaceutical Technology

On Feb. 21, the US Food and Drug Administration issued a warning letter to Wockhardt (Mumbai, India), a drug manufacturer. FDA cited the company for violations of CGMPs in the manufacture of drug products and active pharmaceutical ingredients.

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Eulogies

Hubert J.P. Schoemaker and William T. McCormick. Perhaps we could have not a special day, but just a moment to remember what we owe and who we we owe it to.

Eisai plans $105-million plant. Novartis to build plant in China. BMS building $660-million biologics facility. Slow adoption of RFID. Vaccines update. $14.7 billion in pharma construction in 2006. Chiron sells Betaseron to Schering. Baxter to develop cell based H5N1 vaccine. Drug sales up 5.4%, but growth slowing.

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Despite worries that industry is slow to adopt anticounterfeiting technologies, the 2006 Interphex program is rife with new methods for securing the supply chain.

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On the Bright Side

Vitamin D and a sunny window shed som light on product stability.

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Pharmaceutical Technology Europe

No one is better than Europe when it comes to innovative products at the forefront of the industry

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Pharmaceutical Technology Europe

Once the brightest students are interested in bioprocessing, it is vital that they are prepared and inducted into industry.